Responsibilities

• Preparation for response for audit observations, propose CAPAs, take consent of SMEs for identified actions.


• Track the activity related to audit and response and share update to management till implementation


• To prepare the Quality Risk Management (QRM) for the equipment and process and track the proposed mitigation till implementation.


• Responsible for Change management (Change control); coordination with CFTs for impact assessment till approval.


• Good technical writing skills, and communication as well as presentation skills
  
  

Nice-to-Have

• Science Graduate - BSc / MSc / BPharm / MPharm, etc


• Knowledge on AMPS, GQTS (Global Quality Tracking System), PDOCs (Pfizer Document Management systems) ; experience on EDMS is preferable


• Minimum 5 years relevant experience from Sterile / Injectable Pharmaceutical background
  
  

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control